NCT05715749Completed
Body Weight Support Harness System in Spinal Muscular Atrophy
Exploring the Feasibility and Utility of In-home Body Weight Support Harness System Use in Children Treated for Spinal Muscular Atrophy: a Pilot Study
Source: ClinicalTrials.gov · Last updated 22 Jul 2024
Brief summary (registry, in English)
The goal of this pilot interventional study is to learn about the use of an in-home harness system in children who have been treated for spinal muscular atrophy. The main questions it aims to answer are: 1. Is the in-home body weight support harness system a feasible option for families to use? 2. Is the in-home body weight support harness system a useful tool for children treated for spinal muscular atrophy? 3. Is the in-home body weight support harness system a safe tool for children treated for spinal muscular atrophy? Participants will be given an in-home body weight support harness system and taught how to use it. Families will document how often and for how long they use the system over 6 months. Children will be given tests of motor function at the beginning, 3-months, and 6-months. At the end of the study, families will be asked to fill out a questionnaire about thier experience using the system.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 20 Jan 2023
- Start date
- 7 Sept 2018
- Primary completion date
- 15 Jun 2020
- Lead sponsor
- Nationwide Children's Hospital
- Diseases
- Spinal muscular atrophy
- NCT number
- NCT05715749
What you commit to
- Study type: Interventional
- Participants enrolled: 33
- From 7 Sept 2018 to the primary completion date, 15 Jun 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 4+ copies of SMN2 (historically, SMA Type 3 and 4)
- Evidence of lower limb injury or recent fracture
- In the opinion of the investigator, it was unsafe for the child to participate
Who the study is looking for
- Confirmed heterozygous mutation in SMN1 gene and 2 or 3 copies of SMN2 (historically, SMA Type 1 and Type 2)
- Past or current treatment with nusinersen, onasemnogene abeparvovec, or risdiplam
- Upright head control (defined as the ability to lift head from full forward flexion)
- Weight under or 50lbs
- Confirmed motor delay
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.